PLT/QUIKFLAP 3X2 SD AXS
Received Jun 17, 2024 · Event occurred May 27, 2024
Report 0008010177-2024-00050 · MDR key 19554370
Device
Product problems
- Device Appears to Trigger Rejection
- Patient-Device Incompatibility
- Device Appears to Trigger Rejection
- Patient-Device Incompatibility
Patient
NA · Unknown
- Foreign Body Reaction
- Foreign Body Reaction
Narrative
Description of Event or Problem
IT WAS REPORTED THE SURGEON WILL PERFORM A REVISION SURGERY TO REMOVE THE DEVICES DUE TO PATIENT EXPERIENCING AN ALLERGIC REACTION.
Additional Manufacturer Narrative
THE DEVICE HAS NOT YET BEEN RECEIVED AT THE MANUFACTURER FOR TESTING. AN EVALUATION WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE, AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.
Additional Manufacturer Narrative
UPDATE; H6. CORRECTED DATA: D9, H3. THE REPORTED ALLERGIC REACTION COULD NOT BE CONFIRMED DUE TO A LACK OF ADDITIONAL INFORMATION. CONTACT WITH THE STRYKER SALES REPRESENTATIVE REVEALED THAT THE IMPLANT REMOVAL IS SCHEDULED FOR FALL 2024. SINCE THE LAUNCH OF THE NEURO III SYSTEM IN 2011, ONLY ONE OTHER UNCONFIRMED ALLERGY COMPLAINT HAS BEEN REPORTED, WITH AN UNCERTAIN ROOT CAUSE. STATISTICAL ANALYSIS SHOWS NO INDICATION OF A DESIGN, MATERIAL, OR MANUFACTURING ISSUE. THEREFORE, NO CORRECTIVE ACTIONS ARE NECESSARY AT THIS TIME. THIS COMPLAINT WILL BE MONITORED AS PART OF THE ONGOING TREND ANALYSIS, AND THE RECORD WILL BE REVISITED IF NEW INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THE SURGEON WILL PERFORM A REVISION SURGERY TO REMOVE THE DEVICES DUE TO PATIENT EXPERIENCING AN ALLERGIC REACTION.